Corrective and Preventive Actions (CAPA)
The ED-S3OXT Duodenoscope has several issues related to corrective and preventive actions, including:
- Lack of investigations into failed, returned, and repaired duodenoscopes.
- Inadequate procedures for receiving, reviewing, and evaluating complaints.
- Lack of root-cause investigations into returned duodenoscopes with recurring issues.
Complaints and Corrective Actions
Several complaints have been reported, including:
- Stuck suction buttons.
- Incompatibility with EPX-2500 Processor.
- Water leaks and image failures.
Validation of Reprocessing Instructions
The firm’s reprocessing instructions for the ED-S3OXT Duodenoscope have not been adequately validated, leading to concerns about the effectiveness of the cleaning process.
Manual:
Download: Fujifilm Medical Systems U.S.A. Inc ED-S3OXT Duodenoscope User Manual
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